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U.S. Department of Health and Human Services

Product Classification

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Device immunohistochemistry assay,antibody,progesterone receptor
Regulation Description Immunohistochemistry reagents and kits.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeMXZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.1860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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